CAAmendment object

Authorisation mandatory for

All clinical investigations previously authorised by CA (NB: If the amendment relates to a specific document that has been evaluated exclusively by either the CA or the EC, it only has to be submitted to the respective institution)

Standard notification form available

Yes

Standard notification form

The standard application form to be used for the submission of substantial amendments is provided on the AEMPS website in section: Aclaraciones sobre la aplicación de la normativa de ensayos clínicos:
Anexo 1C: "Solicitud de autorización de una modificación relevante a un ensayo clínico con medicamentos de uso humano a la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) y de dictamen por el Comité Ético de Investigación Clínica (CEIC)."

The application must be in writing, dated and signed by the sponsor and investigator.

Timeline for approval of SA (max nr days)

Other
38

Applicable national legal framework/ Reference

Royal Decree 1090/2015

Additional Information

NB: In case of amendments to clinical trials with gene therapy, somatic cell therapy, or GMO medicinal products, the time span can be extended and will be communicated to the sponsor.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395